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CE Marking: The CE mark is a mandatory
European marking for certain product groups to indicate
conformity with the essential health and safety requirements
set out in European Directives. By adding the mark, the
manufacturer, their authorized representative, or an
importer is declaring that that the products meet all
the essential requirements of all applicable EU
directives. Effectively a CE mark indicates to all
authorities that the product is in compliance with the
essential health and safety requirements of all directives
that apply to the product
CE
marking a product is not an option; it is required by law
if the product falls under one of the European Union New
Approach Directives. The other side of this statement is
that if a product is not covered by a directive then it
should not be CE marked. Does this apply to you? ,see
"Frequently asked question",
"The Directives" or just give
us a call
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CE
marking was introduced throughout the EU for the
following reasons,
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To
harmonise standards through the EU
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Create a single European market
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Protect the consumer/customer
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Protect the environment
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Simplify the lives of manufacturers!
The
last point often comes as a surprise to people
involved in the manufacture of products, however
before the introduction of these harmonized
standards it was not uncommon for a manufacturer
involved in export to have to "jump through a
variety of compliance hoops" for each European
country.
With the exception of some
high-risk products, most products can be “self-
assessed” by the manufacturer. The meaning of
the CE Mark is widely misunderstood, it is not a
quality mark” or “certificate of approval”, it
is a declaration of the supplier's own
responsibility and it allows only for the free
movement of the item with the EEA it also
enables the withdrawal of non-conforming
products to be accomplished more easily. |
Sometimes manufacturer’s decide
to submit their product for voluntary
“certification”, however this does not replace
CE marking and this is stated explicitly in the
European Union publication “Guide to the
implementation of directives based on the New
Approach and the Global Approach”… normally
referred to as the “blue book”
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"Voluntary initiatives, such as
product certification or application
of a quality system, cannot be put
on the same footing as surveillance
activities carried out by an
authority. Still, they can
contribute to the elimination of
risks. However, market surveillance
authorities must be impartial, in
the light of Article 28 of the EC
Treaty, regarding all voluntary
marks, labels and arrangements, and
they may only be taken into
consideration, in a transparent and
non-discriminatory way, for the risk
assessment. Accordingly, products
may not be excluded from market
surveillance operations even if they
have been subject to voluntary
certification or other voluntary
initiatives" |
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A wide range of products require
CE marking ,
these include,
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Medical
devices of all types
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Stand-alone
electrical products
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“Working”
sub-assemblies
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Installations
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Custom-designed units
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Second-hand
equipment
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Upgraded
installations or equipment
The
process that you need to go through to be able
to CE-mark your products vary widely and depends
on a number of things including,
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In a majority
of situations, the New Approach Directives allow
self-declaration in place of third party
(notified body) involvement; but the right to
self-declare compliance with the law means that
a manufacturer must be responsible for
completing all the procedures required by the
law and must be able to prove it. This is done
by the production of Technical Documentation
(normally referred to as a Technical File).
The Technical
File is the written justification that all
aspects of a product are safe and should be
prepared before the product is placed on the
market. The Technical File includes information
that demonstrates the technical basis for
conformity of the product to the applicable
requirements of the directive. The manufacturer
must keep the Technical File for ten years after
the last unit is placed on the market, unless
the directive provides for a different duration. |
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